[Shanghai, China] July 22nd, 2017- Sunshine Guojian Pharma announced today that its bio-manufacturing facilities for the Drug Product of YISAIPU has passed the review inspection of Columbian authorities and therefore maintained the validity of its GMP licenses issued by Columbian government.
The inspection object covers the company’s Bulk Production Line A and Line B, and its Formulation Area Ⅰand Area Ⅲ which all participate the production of YISAIPU, a star biosimilar product of 3S Group. Strictly abiding by the related regulatory rules and principles of Columbian government, and referring to the spirit of US FDA and EMA, the inspection officers mainly focused on the company’s Quality Management System, personnel hygiene, material storage and delivery, facilities and equipments, production management, validation & qualification, deviation investigation and change control, manufacturing process, product shipping and recall, document system and etc. Any a deviation mentioned by the officers should be completely closed during the five-day-long inspection before the final pass approval.
This is the third time that the company’s bio-manufacturing facilities continuously passed the authorities’ review inspection since its first GMP certificate issued by Columbian government in 2006. It’s a solid proof that Sunshine Guojian Pharma’s production and quality management system has been well recognized by international mainstream practice and global market. With this top-level green light given by Columbian government, as the only one authorized CDMO plant for the Drug Product of YISAIPU, Sunshine Guojian Pharma will give stronger support for YISAIPU to lift its overseas market share especially in Latin America.